RecruitingPhase 3NCT05904964

Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)

Disitamab Vedotin or Endocrine Therapy for Patients With Metastatic Breast Cancer With Hormone Receptor-positive and HER2-low-expression


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

288 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Hormone receptor positive, HER2-low expression metastatic breast cancer is the main type of breast cancer, accounting for about 50% - 60%. However, this type of patients lack ideal therapeutic drugs after the failure of first-line standard endocrine therapy, and the median overall survival time is only 30 months. Therefore, finding more efficient and safe therapeutic drugs for these patients has become a big clinical challenge at present. Disitamab Vedotin (DV), as a new class I Antibody-Drug Conjugates drug, can achieve high efficiency and precise tumor killing effect with low toxicity. According to previous study with same sample size, DV also showed good efficacy in metastatic breast cancer with Hormone receptor positive and HER2- low expression as a posterior line treatment.Therefore, we intend to explore the efficacy and safety of DV in the treatment of HER2-low expressioin /Hormone receptor positive metastatic breast cancer patients with endocrine resistance through a scientifically designed, randomized, phase III clinical study.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study (the Rosy Trial) is testing a drug called disitamab vedotin (RC48), which is an antibody-drug combination that targets a protein called HER2, in women with breast cancer that has spread (metastatic) and has hormone receptor-positive, HER2-low expression — a subtype that may respond to this targeted approach. **You may be eligible if...** - You are a female patient aged 18–70 with metastatic breast cancer - Your cancer is hormone receptor-positive (ER and/or PR positive) and HER2-low (a specific level of HER2 expression) - You have already received hormonal (endocrine) therapy - You have at least one measurable tumor site or bone-only disease - Your general health and organ function are adequate **You may NOT be eligible if...** - You received chemotherapy, radiation, immunotherapy, or hormonal therapy within 2 weeks before joining - You had major surgery within the past 2 weeks - You have severe heart disease, including heart attack or stroke in the past year - You have an active autoimmune disease requiring treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisitamab vedotin

Disitamab Vedotin 2mg/kg was injected every 2 weeks,

OTHEREndocrine therapy

Doctors choose endocrine therapy independently


Locations(3)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Second Affiliated Hospital, Shantou University Medical College

Shantou, Guangdong, China

Hainan Qionghai People's Hospital

Qionghai, Hainan, China

View Full Details on ClinicalTrials.gov

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NCT05904964